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The word probiotics is originally taken from Greek word "pro" meaning "for" and "bios" "meaning life". It is defined as a group of microorganisms which when taken live in sufficient quantity are beneficial to host organisms and providing some health benefits to that host organisms on consuming. Most commonly used microbes in probiotics are lactobacillus and bifida bacteria species. Sometimes yeast and bacilli are also added, which provide additional health benefits. Yoghurt and soy yoghurt are most commonly available probiotics products in the market for human consumption. Probiotics can also be taken in the form of dietary supplements. (Cunningham-Rundles, et al. 2000)
Initially, when probiotics were launched they were mainly used as an immunity booster agent, maintaining intestinal flora and stopping growth of other microorganisms which produces toxins. But now they are also being used in treatment of diseases like diarrhoea, atopic diseases, urinary tract infections, chronic intestinal inflammatory diseases, cancer and irritable bowel syndrome. (Dugas, et al. 1999)
Indications where probiotics are used (Reid 2006)
The above diagam shows different uses of probiotics
Some probiotics are used in treatment of gastro enteritis. They act by reducing symptoms, illness and frequency of stool.
Antibiotic associated diarrhoea
It is caused when there is misbalance in colonic mitochondria due to antibiotic therapy or due to growth of clostridium species. Probiotics are mainly used to treat severity and helps in reducing the disease.
Prevents colon cancer
Some of LAB strains show anti mutagenic properties, they can bind to heterocyclic amines which are carcinogenic in nature. Human studies have shown that LAB strains decrease the effect of Î²-glucuronidase, thus lowering risk of colon cancer.
LAB strains are used to lower serum cholesterol levels, by breaking bile in gut, causing inhibiting in its reabsorbing back.
Lowering blood pressure
There are some clinical trials which had shown that some strains of LAB helps in reducing blood pressure.
They act as immunity booster, protecting us from pathogens by the process of competitive inhibition, and also increase Iga cells which help improving phagocytises and increasing number of t-lymphocytes.
Scientific support for their use
This new development is making a new space for food and health industry to make new products which have unique health features for specific population. Use of probiotics for immunity and health benefits are now being supported by strong scientific evidences in which their genetic data and efficacy on humans is given.
Most of the LAB species that are used till date are safe. Till date there are 70 clinical trials done in which >4000 children including infants and new born babies and results obtained are showing that they are safe to use.(Lee and Salminen 1995)
In other case, 12000 patients were taken mostly of them were premature babies and infants which were under weight, on giving them doses of probiotics there were reduction in death rate in that group and also low in deaths due to Â Necrotizing Enter colitis (NEC).(Nayak 2010)
In other case study of 588 premature babies and infants of neonatal intensive care unit (NICU) there was reduction in number of deaths when probiotics was given to them.
(Lee and Salminen 1995)
In one of the case study 204 unnourished children age between 6-24 months were taken and probiotics were given for 6 days for 15 months show improvement in their health.(Cunningham-Rundles, et al. 2000)
There are also various studies which show enormous increase in useful bacteria when given to premature babies, malnourished babies and infants which are born to mothers suffering from HIV.(Reid 2006)
Also there are many organisations like Probiotics European Scientific League( PESU ) , FDA( Food And Drug Association), FAO(Food Agricultural Organisation) which are there to keep control and check on probiotics that are used in market, so that human health may not get effected by them on consuming.
ISAPP (International Scientific Association for Probiotics and Probiotics) formed in 2000 is a scientific association of academic and industrial scientists, which is concerned in research and applied aspects of probiotics, with a main aim of producing good scientific data in favour of probiotics, so that they can be easily used by humans.
Development of new probiotics
Culture, organism and stain that is being used
I am going to develop a new probiotic which will contain species already being used of Lactobacillus and Bifidobacteria in it. The species with stains which I am using are B. infantis 35624 and B. lactis Bb12 of genus Bifidobacteria and L. rhamnosus GG and L. acidophilus NCFM of genus Lactobacillus. It will be available in flavoured yogurt which will be single dose bottles containing 107 - 1010 microorganisms per bottle, so that it will be dose specific and right amount of bacteria are consumed when taken.
When these two species are given through oral route, they have excellent results on human immunity. Both the species have shown measurable growth as early in first week, thus changing unfavourable conditions inside the body into favourable ones. Yoghurt containing these species is consumed annually in tonnes and till date no adverse reactions are reported and I am introducing this product in yogurt form because it is to be used for children and infants, also it is not used for therapeutic use so no need to be given in tablet or capsule form. Also yogurt can be easily given to babies for a long duration of time to increase their immunity. (Dugas, et al. 1999)
Benefits of this product
Can survive during cultivation, processing and storage before consumption.
Provide health benefits on consuming.
Remains alive in gastric, pancreatic and bile secretions.
Induce host cells when it comes in contact with them.
Reduces pathogenic effects by producing acids like H2O2, which stops growth of clostridium species.
Helps to maintain natural flora.
Non carcinogenic, safe, non pathogenic and non invasive.
Shows antimicrobial activity.
Survive through stomach passage thus helps in reduction of free amines present in intestine.
Doesn't cause resistant to antibiotics.
Boosts immunity levels.
Mechanism of action (Nayak 2010)
GI tract is one of the important organs which play a major role in function of probiotics. It mainly consists of 10 trillion organisms in it. Intestinal epithelial cells, present in GIT can distinguish between pathogenic and non pathogenic bacteria.
Its mechanism include
Change in GI immunity by cytokinesis or in stain specific manner.
Gas producing organisms are removed.
Change in flora by changing acidic nature of colon.
Epithelial barrier is enhanced.
The combination which is used is more beneficial to children, it helps them to increase their immunity levels, which helps them to fight with pathogens present in their body and stay healthy and fit.
The target customers will include
New born babies
Under weight born babies
Children under age of 15 years
Babies born to mothers suffering from HIV
There are many case studies which prove that this combination of probiotics when given to above group is beneficial for them. By giving this combination to premature babies there has been an increase in number of good bacteria in them which finally improves their health. Also this combination had increase weight in babies which were born underweight. This combination of bacteria is beneficial for infants and children, by boosting their immunity levels. This combination is also good to increase immunity in babies which are born to mothers suffering from HIV. In short, this combination of bacteria will help these groups of babies and children to boost up their immunity levels to fight with the infections in them and to live a normal life.(Cunningham-Rundles, et al. 2000)
Guidelines which have to be followed before getting this product in market
There are several guidelines provided by different organisations which one has to follow before launching this product in the market.
The guidelines provided by WHO which is accepted all around the world has to follow before making the probiotics useable in market by humans. They are
Company has to provide literature of safe use of species
No antibiotic resistance should be there
No virulence characters should be present
No toxins should be formed
Checking of haemolytic activity
Side effects that can occur in humans
Examining of metabolic activities, for instance checking for production of lactase and deconstruction of bile salt
Post market survey for adverse effects
European Food and Safety Authority (EFSA)
This association had following criteria for use of probiotics in Europe
Organism should be full identified that its genus, species and stain should be fully known.
Data about organism's history, its use in industry, and its doses in humans should be known.
Should be fit for uptake
Should be non pathogenic, non carcinogenic and non degrading
Does not cause antibiotic resistance
Should survive in intestinal tract
One phase 2 study should be in its support
Should stay viable at time of processing and storage
In vivo/ animal study should be done
Strains that are used are to be kept at international culture centre
Pulse field gel electrophoresis should be used for stain typing
Its DNA should be identified and also 16 RNA sequences should be known.
End products which are formed should be known
Should stop pathogens growth
Should posses antimicrobial activity
With the guidelines mentioned in EFSA this community had provided certain more guidelines for evaluation of lactic acid for human use
DNA sequencing should be done by some expert lab
Animals model mostly rats should be used to check its safety
Human study should be done randomly, double blind and with placebo control
Labelling of probiotics
This is one of the most important concerns in launching of probiotics. It should contain
Genus, species and stains that is used
Minimum number of viable bacteria that will present at the end of shelf life
Company contact details
Side effects if there are any